An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Prostate Cancer Clinical Trial

Official title:

Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540392
• Other study ID #: 22-270
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 9, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kevin Liou, MD
• Phone: 646-608-8558
• Email: liouk[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older
• Prior PC diagnosis
• No evidence of Prostate Cancer
• Clinically meaningful nocturia, defined as =2 nocturia episodes every night for the past month

Exclusion Criteria:

• <1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT)
• Score of =5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea
• Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome)
• Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia)
• Initiation of new medications for urinary symptoms in the past 4 weeks
• Altered dosing of medications for urinary symptoms in the past 4 weeks
• Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study
• Implanted electronically charged medical device
• Unable to provide consent for himself
• Unwilling to adhere to all study-related procedures

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Survivorship

Intervention

Procedure:
• Acupuncture
10 treatments of acupuncture over the course of 10 weeks

Other:
• Waitlist Control
The waitlist control group will not receive any acupuncture treatments during the 14-week waiting period. Patients in waitlist control group will have the option to receive up to 10 acupuncture treatments after a 14-week waiting period.
• Questionnaires
Patients will complete Patient Reported Outcomes (PRO)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center Suffolk - Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	MSK at Ralph Lauren (Consent Only)	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success	If a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center